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NDC 60219-1652-03 brexpiprazole 2 mg/1 Details
brexpiprazole 2 mg/1
brexpiprazole is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals NY LLC. The primary component is BREXPIPRAZOLE.
MedlinePlus Drug Summary
Brexpiprazole is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions) in adults and children 13 years of age and older. It is also used with an antidepressant to treat depression when symptoms cannot be controlled by the antidepressant alone. Brexpiprazole is also used to treat agitation in people with dementia due to Alzheimer's disease (a brain disease that slowly destroys the memory and ability to think, learn, communicate, and handle daily activities). Brexpiprazole is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.
Related Packages: 60219-1652-03Last Updated: 04/28/2024
MedLinePlus Full Drug Details: Brexpiprazole
Product Information
| NDC | 60219-1652 |
|---|---|
| Product ID | 60219-1652_10d2049f-580a-4add-abab-77e458ccb246 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | brexpiprazole |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | brexpiprazole |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 2 |
| Active Ingredient Units | mg/1 |
| Substance Name | BREXPIPRAZOLE |
| Labeler Name | Amneal Pharmaceuticals NY LLC |
| Pharmaceutical Class | Atypical Antipsychotic [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA213562 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 60219-1652-03 (60219165203)
| NDC Package Code | 60219-1652-3 |
|---|---|
| Billing NDC | 60219165203 |
| Package | 1 BOTTLE, PLASTIC in 1 CARTON (60219-1652-3) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2023-02-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |